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ELA026 treatment for secondary hemophagocytic lymphohistiocytosis (sHLH).

A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Phase2; Phase3 Interventional Electra Therapeutics Inc. · NCT05416307

This study will try ELA026, a monoclonal antibody, in children and adults with secondary HLH to see if it reduces the disease-driving immune activation and improves clinical outcomes.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment156 (estimated)
Ages6 Years and up
SexAll
SponsorElectra Therapeutics Inc. Industry-sponsored
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT05416307 on ClinicalTrials.gov

What this trial studies

The study enrolls pediatric and adult participants with newly diagnosed or relapsed/refractory secondary HLH who meet HLH-2004 criteria. Part 1 used dose-escalation and fixed-dose cohorts to evaluate safety, pharmacokinetics, and pharmacodynamics of intravenous and subcutaneous ELA026 and to select a Phase 3 dose and schedule. Part 2 (SURPASS) is an open-label, single-arm, multicenter registrational study using historical controls to test efficacy in treatment‑naïve adult and pediatric cohorts, including malignancy-associated and other triggers. Participants receive ELA026 over a defined treatment period with regular clinical and laboratory monitoring for response and safety.

Who should consider this trial

Good fit: Adults and children with secondary HLH who meet the study's diagnostic criteria, including newly diagnosed treatment‑naïve and selected relapsed/refractory cases, and who can receive IV or subcutaneous monoclonal antibody therapy are ideal candidates.

Not a fit: Patients with primary (genetic) HLH, those who do not meet the protocol diagnostic criteria, or those with contraindications to monoclonal antibody therapy may not receive benefit from this study.

Why it matters

Potential benefit: If successful, ELA026 could rapidly reduce harmful immune overactivation in sHLH and offer a targeted therapy that improves organ function and survival.

How similar studies have performed: Other immune‑targeting treatments such as emapalumab and JAK inhibitors have shown benefit in HLH, but SIRP‑directed depletion of myeloid and T cells is a novel approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria for Part 1:

1. ≥12 years at the time of HLH diagnosis (Cohort 1).
2. ≥6 years at the time of HLH diagnosis (Cohort 2-3).
3. Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
4. Treatment naïve or early refractory (Cohort 3).
5. Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria.

Key Inclusion Criteria for Part 2:

1. Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH.
2. Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH.
3. Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
4. Cohort B: 13 to 17 years olds with newly diagnosed, treatment-naïve sHLH.
5. Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort).
6. Cohort B: 6 to 12 year olds, with newly diagnosed, treatment-naïve sHLH (after completion of safety lead-in cohort).

Key Exclusion Criteria for Part 1:

1. Known or previous treatment for primary HLH
2. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
3. Unknown trigger for sHLH
4. Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
5. Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
6. Ongoing administration of any therapies used to treat HLH (excluding dexamethasone)
7. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening

Key Exclusion Criteria for Part 2:

1. Refractory sHLH (except for the safety lead-in cohort for 6-12 year olds in Cohort B).
2. Known or suspected primary or hereditary HLH.
3. Severe organ dysfunction.
4. Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures.
5. End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH.
6. Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026.

Where this trial is running

Birmingham, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Secondary Hemophagocytic Lymphohistiocytosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.